Accutane may pose risks
Acne drug could harm pregnancies
By Katie Kellogg, senior writer
Posted on September 11, 2006

For patients who take Accutane, a drug that treats a serious form of acne known as nodular acne, filling their prescription is a complicated process.

This is because in March, the Food and Drug Administration approved a stringent new program known as iPledge to monitor the distribution of Accutane. The program was implemented after serious concerns arose about the correlation between the use of Accutane and serious birth defects occurring in the unborn children of women using the drug.

“Accutane is definitely not safe in anyone who is pregnant or wants to become pregnant,” said Craig Czarsty, a family physician in Connecticut.

The iPledge program requires that all users, prescribers and distributors of the drug must register with iPledge before they can receive or administer treatment. Female patients of childbearing age must pledge to use two forms of birth control for the month before treatment, while they are on the drug, and the month after treatment ends. Additionally, female patients are required to test negative to two pregnancy tests before they can be given the drug, and must also agree to take a pregnancy test before each refill.

According to the FDA Web site, aside from causing birth defects, Accutane has also been linked to suicide and depression in some patients. However, so far there is no concrete evidence to determine whether Accutane caused these tendencies to occur in patients or if there were pre-existing problems that would have developed even without the drug. 

Additionally, the FDA warns that there are other serious side effects of Accutane, including causing the amount of lipids and cholesterol in the blood to rise, and problems with the abdomen, brain, blood sugar, hearing and vision, as well as decreasing the patient’s red and white blood cell count.

Angelina Ramos, a senior at Florida State University, who was on Accutane for two months in 2002 before iPledge was implemented, said she stopped taking the drug after her mother began researching Accutane on the Internet and became concerned about some of the potential side effects. Ramos said she felt misled by her doctors about some of the dangers of the drug.

“If I had to go through it again, I would not go through all this trouble to get Accutane because the side effects are not worth the benefits,” Ramos said.

Still, for patients who have struggled with nodular acne, Accutane may appear to be a miracle cure, after all other treatments have failed.
“It can be life-changing for some patients,” Czarsty said.

However, getting a hold of the medication may prove to be difficult. According to an August 2006 survey conducted by the American Academy of Dermatology Association, more than 90 percent of the 400 dermatologists interviewed had experienced problems with the iPledge system.

The survey reports that some of the main difficulties with the program included technical problems with the system, issues getting help from iPledge staff, difficulties with appointment scheduling and the confusing nature to the program to both prescribers and patients.
Despite the barriers, many agree that there needs to be regulations regarding the use of the drug.

JMU senior Keara Linehan agreed that Accutane should be closely regulated. “If they know the potential problems with it, then they should do everything they can to keep them from happening,” she said.

Said senior Laura Hinton, “It is an optional drug. “If [people] are going to choose to take Accutane, having a child with birth defects is a serious thing. They need to take responsibility to prevent that.”

Still, for patients who have struggled with nodular acne, Accutane may appear to be a miracle cure, after all other treatments have failed.

“It can be life-changing for some patients,” Czarsty said.

However, getting a hold of the medication may prove to be difficult. According to an August 2006 survey conducted by the American Academy of Dermatology Association, more than 90 percent of the 400 dermatologists interviewed had experienced problems with the iPledge system.

The survey reports that some of the main difficulties with the program included technical problems with the system, issues getting help from iPledge staff, difficulties with appointment scheduling and the confusing nature to the program to both prescribers and patients.

Despite the barriers, many agree that there needs to be regulations regarding the use of the drug.

JMU senior Keara Linehan agreed that Accutane should be closely regulated. “If they know the potential problems with it, then they should do everything they can to keep them from happening,” she said.

Said senior Laura Hinton, “It is an optional drug. “If [people] are going to choose to take Accutane, having a child with birth defects is a serious thing. They need to take responsibility to prevent that.”